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Session 7, Track A: Optimizing Canadian Submissions: Risk-Based Framework Approach for Package Inserts, XML PM Authoring and CMC Trends
Session Chair(s)
Adesola Adeyemi, MSc
Regulatory Affairs Project Manager, Bayer Inc., Canada
Session 7, Track A: Optimizing Canadian Submissions: Risk-Based Framework Approach for Package Inserts, XML PM Authoring and CMC Trends
Speaker(s)
Amanda Starr, PhD
Scientific Evaluator - Pharmaceutical Drugs Directorate, Health Canada, Canada
Advancing a Risk-Based Framework for Package Insert Decision-Making Across Directorates
Kenneth Gutierrez
Senior Product Manager, Docuvera, United States
CMC Submission Quality as Supply Risk: How Structured Authoring Reduces Variability and Regulatory Delay
Melissa Bieman, PhD
Manager, Regulatory Affairs, Intrinsik Corp., Canada
XML PM Authoring: Practical Strategies, Challenges, and Insights